NCT05680935

Brief Summary

It's a non-randomized, intervention, prospective, single-center study. The aim of the work is to identify of biomarkers of unstable atherosclerosis in brachiocephalic arteries Tasks:

  • identify microRNAs, the expression of which is characteristic of unstable atherosclerotic lesions;
  • to assess the relationship of miRNA and trimethylamine N-oxide with the progression of unstable atherosclerotic lesions;
  • to determine the effect of the level of plasma trimethylamine N-oxide on the progression of atherosclerotic lesions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2024

Completed
Last Updated

July 16, 2025

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

December 21, 2022

Last Update Submit

July 15, 2025

Conditions

Atherosclerosis of Artery

Keywords

unstable plaquemiRNAtrimethylamine N-oxideatherosclerosiscarotid artery

Outcome Measures

Primary Outcomes (5)

  • blood microRNA

    * blood sampling from the cubital vein 20.0 ml before surgery * centrifuge ethylenediaminetetraacetic acid (EDTA) tubes with blood (ELMI centrifuge, Centrifuge model CM-6M) once at 1000 g for 10 minutes to sediment the cells; * select from above ¾ of the plasma volume, so as not to capture cells, into a new empty tube; * centrifuge the plasma at 2500 g for 15 minutes to sediment platelets. Remove ¾ of the supernatant without touching the pellet and transfer to a new tube. Repeat the procedure again; * Aliquot the supernatant taken a second time into 1.0 ml Eppendorf tubes. * Freeze (Thermo Scientific refrigerator-freezer) and store at -70˚C, -80˚C.

    at study entry, before carotid endarterectomy.

  • plaque microRNA

    \- after receiving an atherosclerotic plaque and adjacent intima during the operation of carotid endarterectomy The atherosclerotic plaque obtained during the surgical intervention (carotid endarterectomy) is cut in half, the adjacent part of the intima is cut off. One half of the plaque is placed in a tube with 10% neutral buffered formalin solution and sent for histological examination. The second half and intima are placed in different test tubes with RNAprotect Tissue Reagent (Qiagen), cooled at +2 ˚С +4 ˚С, then frozen (Thermo Scientific refrigerator-freezer) and stored at -70˚С, -80˚С.

    immediately after carotid endarterectomy

  • blood TMAO

    * blood sampling from the cubital vein 20.0 ml before surgery * centrifuge the ethylenediaminetetraacetic acid (EDTA) tube with blood (ELMI centrifuge, Centrifuge model CM-6M) at 2300 g for 15 minutes; * take 1.0 ml from the obtained plasma into 2 Eppendorf tubes; * Freeze (Thermo Scientific refrigerator-freezer) and store at -70˚C, -80˚C.

    at study entry, before carotid endarterectomy

  • histological examination of atherosclerotic plaque

    \- after receiving an atherosclerotic plaque and adjacent intima during the operation of carotid endarterectomy The atherosclerotic plaque obtained during the surgical intervention (carotid endarterectomy) is cut in half, the adjacent part of the intima is cut off. One half of the plaque is placed in a tube with 10% neutral buffered formalin solution and sent for histological examination.

    immediately after carotid endarterectomy

  • intima microRNA

    * after receiving an atherosclerotic plaque and adjacent intima during the operation of carotid endarterectomy * the intima obtained during the surgical intervention (carotid endarterectomy) is placed in a tube with RNAprotect Tissue Reagent (Qiagen), cooled at +2 ˚С +4 ˚С, then frozen (Thermo Scientific refrigerator-freezer) and stored at -70˚С, -80˚С.

    immediately after carotid endarterectomy

Study Arms (2)

atherosclerosis of the brachiocephalic arteries

EXPERIMENTAL

The recruitment of patients will be carried out at the University Clinical Hospital No. 1 of the Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University). The study will include up to 50 people - the study group with atherosclerosis of the brachiocephalic arteries.

Diagnostic Test: blood microRNADiagnostic Test: plaque and intima microRNADiagnostic Test: histological examination of the plaqueDiagnostic Test: blood level trimethyl N-oxide

No brachiocephalic atherosclerosis

EXPERIMENTAL

The recruitment of patients will be carried out at the University Clinical Hospital No. 1 of the Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University). Up to 30 people - the control group without brachiocephalic atherosclerosis.

Diagnostic Test: blood microRNADiagnostic Test: blood level trimethyl N-oxide

Interventions

blood microRNADIAGNOSTIC_TEST

all patients will receive blood (20 ml) from the cubital vein for microRNA isolation.

No brachiocephalic atherosclerosisatherosclerosis of the brachiocephalic arteries
plaque and intima microRNADIAGNOSTIC_TEST

The resulting surgical material will be sent for microRNA isolation.

atherosclerosis of the brachiocephalic arteries
histological examination of the plaqueDIAGNOSTIC_TEST

The resulting surgical material (atherosclerotic plaque) will be sent for histological examination.

atherosclerosis of the brachiocephalic arteries
blood level trimethyl N-oxideDIAGNOSTIC_TEST

all patients will receive blood (20 ml) from the cubital vein for determination of plasma trimethyl N-oxide (TMAO) content.

No brachiocephalic atherosclerosisatherosclerosis of the brachiocephalic arteries

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Availability of written informed consent to participate in research work;
  • Age from 18 to 85 years;
  • Availability of data from a general blood test, blood lipid profile (total cholesterol, very low density lipoproteins, low density lipoproteins, high density lipoproteins, triglycerides);
  • Absence of clinical signs of atherosclerosis of brachiocephalic arteries (no stroke, transient ischemic attack. On auscultation of the carotid arteries, there are no additional noises);
  • Absence of signs of atherosclerosis of the brachiocephalic arteries according to ultrasound duplex scanning (USDS) and/or multispiral computed tomography (MSCT) angiography of the brachiocephalic arteries;
  • Conducted outpatient visit at a research center with clinical and biochemical blood tests performed, ultrasound examination of arterial vessels and/or multispiral tomography of arterial vessels with contrast enhancement and/or hospitalization at a research center.
  • Chronic kidney disease stage 3b and above (glomerular filtration rate \< 45 ml / min / 1.73 sq.m);
  • The presence of severe somatic pathology (with the exception of atherosclerosis of the carotid arteries and conditions caused by it), reducing life expectancy to less than 6 months;
  • Chronic somatic diseases in the acute stage;
  • Weight less than 40kg and more than 125kg;
  • Pregnancy.

You may not qualify if:

  • \. Refusal to continue participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, 119991, Russia

Location

Related Links

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Anastasiia Lomonosova, no

    I.M. Sechenov First Moscow State Medical University (Sechenov University)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 11, 2023

Study Start

September 5, 2022

Primary Completion

February 28, 2024

Study Completion

February 29, 2024

Last Updated

July 16, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

not recommended by the ethical committee

Locations

RU(1)